Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

The purpose of this study is to develop a standardized assessment for patients treated for venous malformations (VM).

Venous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. The impact of VM on patient quality of life varies based on the location and size of the malformation.

A patient reported outcome (PRO) is a patient's own account of patient's health condition. PRO measures are valued to clinicians, as many treatment effects are known only to the patient. No studies to date have analyzed the validity of existing PRO measures for VM patients.

Current assessment does not include all symptoms or take in to account the relevance of VM location. Past studies show a discrepancy between treatment outcomes reported by patients and physicians. Therefore, there is a need to develop VM-specific PROs to better understand the effectiveness and benefits of treatment for VM.

Recruiting

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Key information

Conditions

Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities VM - Vascular Malformation

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations.
Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.
Vascular malformation symptoms significant enough to seek treatment.

Exclusion criteria

Patients with extensive VM not suitable for sclerotherapy.
Prior therapy for treatment of a VM within 3 months.
Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).

Treatment and study plan

Primary outcomes

Change in patient reported VM pain

Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year

Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
Change in patient reported VM impact on daily life

Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year

Patients are asked to rate the impact that their VM has on daily life with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Change in patient reported efficacy of treatment

Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year

Patients are asked to rate the efficacy of their treatment with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Change in patient reported relevancy of the PROVEN Questionnaire

Time frame: 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year

Patients are asked to rate the personal relevancy and clarity of the survey questions with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".

Study contacts

Contact information is provided by the study sponsor or research team.

Clifford R Weiss, MD

CONTACT

[email protected]

410-614-0601

Hannatu A Bwayili, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2026
First posted: Sep 26, 2019
Registry last updated: Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting